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Executive Summary

Pfizer's once-daily selective alpha blocker Cardura (doxazosin) will enter the U.S. market with the sales support of about 800 representatives from the Roerig and Pfizer Labs cardiovascular specialty force, the company told investment analysts at an Oct. 26 meeting in New York City. Cardura has been "approvable" at FDA since the beginning of August. The antihypertensive was submitted to FDA for approval in mid-March 1987 and received an advisory committee review in early May 1989. Cardura's approval reportedly was held up for an inspection of Pfizer's manufacturing processes for the new product. That inspection took place after Oct. 1; Pfizer believes approval is imminent. The delay may embody the problems being experienced by individual companies and products due to two recent problems coloring FDA's overall ability to act: the generic drug investigations and the government budget/deficit debates. The inspection was necessary to fulfill FDA's new pre-approval guidelines. Those late-August guidelines have been tightened as a result of the inspectional findings that derived from enforcement reviews in the wake of the generic drug investigations ("The Pink Sheet" Sept. 17, p. 6). As a result of the recent federal budget uncertainties, FDA travel was restricted, and the Pfizer inspection was delayed. Pfizer ironically has another major product tied up in the approval process as a result of the government's larger budget crisis. Its antidepressant sertraline was scheduled for an advisory committee review on Oct. 1, but the meeting was cancelled due to FDA's concern about paying committee members under a possible Gramm-Rudman budget cutback. Sertraline has been rescheduled for an advisory committee review Nov. 19 (see related item, p. 8) Cardura is currently available in 12 foreign countries and will generate $35 mil. in sales in 1990, the company estimated. According to slides prepared for the Oct. 26 meeting, Pfizer described the drug as "extremely safe" and "well-tolerated," with a "favorable lipid profile" and "no metabolic side effects." Pfizer aggressively has been pursuing the lipid profile aspect of Cardura, and that claim may also be complicating final labeling approval. FDA's Cardio-Renal Advisory Committee recommended against including information on the lipid effects of doxazosin during the review of the drug in 1989 ("The Pink Sheet" May 8, 1989, p. 6). At that point, Pfizer had retrospective data from the antihypertensive clinical trials and early Phase I data from a large Treatment of Mild Hypertension Study (TOMHS). The company reported that Cardura has a wide clinical trial experience; the drug has been the subject of over 160 clinical studies involving more than 17,000 patients worldwide. Pfizer is now collecting information for a followup filing with FDA for the product's use in treating benign prostatic hypertrophy. The new cardiovascular specialty sales force is an outgrowth of Pfizer's success in shifting the market from its standard-release Procardia to the Alza-developed sustained-release Procardia XL. It also reflects the broad group of products in the early stages of market introduction or at the end of the NDA pipeline at Pfizer. Overall, the company's U.S. sales force has expsnded 25% in the last year to 1,500 personnel. Most of that increase was in the company's Roerig division, which increased from 500 to 750 marketing people. Roerig is now as large as the company's Pfizer Labs division's sales force. The cardiovascular specialty force is one of three new specialty forces within the Pfizer Labs sales division. In addition to cardiovascular, there is a hospital field force and a managed care field force. All three are composed mostly of senior sales representatives. Procardia XL is currently accounting for about two-thirds of Pfizer's total monthly prescriptions for nifedipine: 625,000 out of approximately 1 mil. monthly scripts. Introduced in October 1989, Procardia XL has made the combined Pfizer nifedipine line the current leader among new prescriptions in the cardiovascular field (surpassing Merck's Vasotec), Pfizer told the analysts. Total Procardia sales were $551 mil. for the first nine months of 1990, up 57% from last year. For the full year, Pfizer is estimating Procardia line sales of over $700 mil. with about 60% of the sales volume from the new formulation. Pfizer's current pharmaceutical sales growth is also reflecting the effect of the antifungal Diflucan (fluconazole). The product is on track for over $90 mil. in 1990 sales in the U.S. after nine months of sales. The product already has generated $149 mil. in the first nine months worldwide. Pfizer showed the analysts that Diflucan has almost doubled the total U.S. market for antifungals from just over $100 mil. in 1989 to a level over $200 mil. this year. Projected added uses for fluconazole include burn treatment, organ transplantation, cancer and diabetes, Pfizer told the analysts. The expanded uses of antifungals could take that market to $1 bil. annually by 1995, the company maintained. Pfizer's research budget has been expanding at a pace ahead of corporate sales: the corporate R&D budget is slated to reach $625 mil. in 1990, up almost 18% over 1989 expenditures; corporate sales were advancing at an 11% rate through the nine-month mark. Pfizer noted that about 85% of its corporate R&D budget has been going to the ethical pharmaceutical and medical device area. To highlight the new development spending activities, Pfizer showed the analysts a slide comparing the annual number of clinical studies initiated during the 1980s. For 1990, that figure tops 800, compared to under 100 in 1980 and about 600 in 1988. Those studies include NDA and "marketing studies," according to Pfizer. The marketing studies represent less risky R&D investments to the financial community but have been looked at with some skepticism on Capitol Hill and among industry critics ("The Pink Sheet" Nov. 13, 1989, T&G-4).

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